Duns Number:942377524
Device Description: The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The h The Titan Modular Total Shoulder Humeral Head has a concentric articulating surface. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the polyethylene cemented glenoid bone. It is intended for optimal osteotomy coverage and soft tissue balancing.
Catalog Number
MHH-0923-010-4821C
Brand Name
Titan™ Total Shoulder System
Version/Model Number
MHH-0923-010-4821C
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K142413
Product Code
HSD
Product Code Name
PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Public Device Record Key
e8388106-aced-462c-8df4-872ab786726d
Public Version Date
June 23, 2020
Public Version Number
4
DI Record Publish Date
October 09, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1909 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1404 |
| 3 | A medical device with high risk that requires premarket approval | 12 |
| U | Unclassified | 15 |